APPLICATION
ANDA074532
TYPE
ANDA
ORIGINAL APPROVAL
1997-03-28
LATEST ACTION
2020-03-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
CAPTOPRILPrescription
CAPTOPRIL 12.5MG · TABLET · ORAL
CAPTOPRILPrescription
CAPTOPRIL 100MG · TABLET · ORAL
CAPTOPRILPrescription
CAPTOPRIL 25MG · TABLET · ORAL
CAPTOPRILPrescription
CAPTOPRIL 50MG · TABLET · ORAL
Approval history
2020-03-11Labeling · Supplement 12 · standardAP
2020-03-11Labeling · Supplement 10 · standardAP
2015-10-30Labeling · Supplement 8 · standardAP
2015-01-20Labeling · Supplement 7 · standardAP
2002-04-22Manufacturing (CMC) · Supplement 3AP
2002-04-22Manufacturing (CMC) · Supplement 2AP
1997-09-05Labeling · Supplement 1AP
1997-03-28OriginalAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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